Impact of anti-CGRP mAb discontinuation and reinitiation in chronic migraine

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Key clinical point: Discontinuation of anticalcitonin gene-related protein (CGRP) monoclonal antibodies (mAb) leads to a progressive increase in monthly migraine days (MMD) and analgesic use from the first month, which, on reinitiation, revert to values comparable with those in the last month of treatment.

 

Main finding: At months 2 and 3 after discontinuation, a significant increase in MMD (P = .003 and P < .001, respectively) and analgesic use (both P < .001) was observed compared with month 12 of treatment. In the reinitiation month, the MMD (P = .40), days with ≥1 analgesic used (P = .83), and number of analgesics used (P = .74) were similar to the treatment month 12 values.

 

Study details: Findings are from a single-center, prospective, observational study involving 44 patients >18 years of age with treatment-resistant chronic migraine who received erenumab or galcanezumab for 12 months before a 3-month treatment discontinuation phase and 1 month of reinitiation.

 

Disclosures: The study received no specific funding. Some authors reported receiving personal fees or grants from various sources.

 

Source: Iannone LF et al. Eur J Neurol. 2022 (Jan 31). Doi: 10.1111/ene.15260

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Key clinical point: Discontinuation of anticalcitonin gene-related protein (CGRP) monoclonal antibodies (mAb) leads to a progressive increase in monthly migraine days (MMD) and analgesic use from the first month, which, on reinitiation, revert to values comparable with those in the last month of treatment.

 

Main finding: At months 2 and 3 after discontinuation, a significant increase in MMD (P = .003 and P < .001, respectively) and analgesic use (both P < .001) was observed compared with month 12 of treatment. In the reinitiation month, the MMD (P = .40), days with ≥1 analgesic used (P = .83), and number of analgesics used (P = .74) were similar to the treatment month 12 values.

 

Study details: Findings are from a single-center, prospective, observational study involving 44 patients >18 years of age with treatment-resistant chronic migraine who received erenumab or galcanezumab for 12 months before a 3-month treatment discontinuation phase and 1 month of reinitiation.

 

Disclosures: The study received no specific funding. Some authors reported receiving personal fees or grants from various sources.

 

Source: Iannone LF et al. Eur J Neurol. 2022 (Jan 31). Doi: 10.1111/ene.15260

Key clinical point: Discontinuation of anticalcitonin gene-related protein (CGRP) monoclonal antibodies (mAb) leads to a progressive increase in monthly migraine days (MMD) and analgesic use from the first month, which, on reinitiation, revert to values comparable with those in the last month of treatment.

 

Main finding: At months 2 and 3 after discontinuation, a significant increase in MMD (P = .003 and P < .001, respectively) and analgesic use (both P < .001) was observed compared with month 12 of treatment. In the reinitiation month, the MMD (P = .40), days with ≥1 analgesic used (P = .83), and number of analgesics used (P = .74) were similar to the treatment month 12 values.

 

Study details: Findings are from a single-center, prospective, observational study involving 44 patients >18 years of age with treatment-resistant chronic migraine who received erenumab or galcanezumab for 12 months before a 3-month treatment discontinuation phase and 1 month of reinitiation.

 

Disclosures: The study received no specific funding. Some authors reported receiving personal fees or grants from various sources.

 

Source: Iannone LF et al. Eur J Neurol. 2022 (Jan 31). Doi: 10.1111/ene.15260

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Eptinezumab offers effective migraine treatment irrespective of patient baseline characteristics

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Key clinical point: The efficacy and safety of eptinezumab in preventing migraine realized in the PROMISE-1 and PROMISE-2 trials remain unperturbed by the intrinsic baseline characteristics of the study participants, including sex, age, and body mass index (BMI).

 

Main finding: The ≥50% migraine responder rate (MRR) was ≥10% higher with eptinezumab relative to placebo for most demographic factors, except in the case of obesity; although patients with a BMI of 30-35 kg/m2 receiving eptinezumab vs. placebo showed improved ≥50% MRR, the separation was <10%. Eptinezumab was generally safe, and no new treatment-emergent adverse events were identified.

 

Study details: This was a post hoc subgroup analysis of adult patients with episodic or chronic migraine from the phase 3 PROMISE-1 and PROMISE-2 trials, respectively, which included a total of 1,960 patients in the safety analysis and 1,737 patients (99.8%) in the efficacy analysis.

 

Disclosures: The study received financial support from H. Lundbeck A/S. The authors disclosed having no conflicts of interest.

 

Source: Martin V et al. Clin Ther. 2022 (Feb 9). Doi: 10.1016/j.clinthera.2022.01.006

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Key clinical point: The efficacy and safety of eptinezumab in preventing migraine realized in the PROMISE-1 and PROMISE-2 trials remain unperturbed by the intrinsic baseline characteristics of the study participants, including sex, age, and body mass index (BMI).

 

Main finding: The ≥50% migraine responder rate (MRR) was ≥10% higher with eptinezumab relative to placebo for most demographic factors, except in the case of obesity; although patients with a BMI of 30-35 kg/m2 receiving eptinezumab vs. placebo showed improved ≥50% MRR, the separation was <10%. Eptinezumab was generally safe, and no new treatment-emergent adverse events were identified.

 

Study details: This was a post hoc subgroup analysis of adult patients with episodic or chronic migraine from the phase 3 PROMISE-1 and PROMISE-2 trials, respectively, which included a total of 1,960 patients in the safety analysis and 1,737 patients (99.8%) in the efficacy analysis.

 

Disclosures: The study received financial support from H. Lundbeck A/S. The authors disclosed having no conflicts of interest.

 

Source: Martin V et al. Clin Ther. 2022 (Feb 9). Doi: 10.1016/j.clinthera.2022.01.006

Key clinical point: The efficacy and safety of eptinezumab in preventing migraine realized in the PROMISE-1 and PROMISE-2 trials remain unperturbed by the intrinsic baseline characteristics of the study participants, including sex, age, and body mass index (BMI).

 

Main finding: The ≥50% migraine responder rate (MRR) was ≥10% higher with eptinezumab relative to placebo for most demographic factors, except in the case of obesity; although patients with a BMI of 30-35 kg/m2 receiving eptinezumab vs. placebo showed improved ≥50% MRR, the separation was <10%. Eptinezumab was generally safe, and no new treatment-emergent adverse events were identified.

 

Study details: This was a post hoc subgroup analysis of adult patients with episodic or chronic migraine from the phase 3 PROMISE-1 and PROMISE-2 trials, respectively, which included a total of 1,960 patients in the safety analysis and 1,737 patients (99.8%) in the efficacy analysis.

 

Disclosures: The study received financial support from H. Lundbeck A/S. The authors disclosed having no conflicts of interest.

 

Source: Martin V et al. Clin Ther. 2022 (Feb 9). Doi: 10.1016/j.clinthera.2022.01.006

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Having migraine increases the risk of developing neovascular AMD

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Key clinical point: Patients with migraine present with a 20% higher risk of developing neovascular age-related macular degeneration (AMD) compared with individuals without migraine.

 

Main finding: A significantly higher proportion of patients with neovascular AMD vs. control individuals had migraine before the index date (6.1% vs. 4.9%; P < .001), with an adjusted (for age, sex, monthly income, geographic location, urbanization, hyperlipidemia, diabetes, coronary heart disease, hypertension, and cataract surgery) odds ratio of 1.201 (P < .001).

 

Study details: This nationwide, population-based study included 20,333 patients aged 40 years or older diagnosed with neovascular AMD in at least 2 claims, with the first diagnosis date defined as the index date. They were propensity score-matched (1:4) with 81,332 nonneovascular AMD control individuals.

 

Disclosures: No source of funding was declared. None of the authors identified any conflicts of interest.

 

Source: Kuang TM et al. Sci Rep. 2022;12:1792 (Feb 2). Doi: 10.1038/s41598-022-05638-5

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Key clinical point: Patients with migraine present with a 20% higher risk of developing neovascular age-related macular degeneration (AMD) compared with individuals without migraine.

 

Main finding: A significantly higher proportion of patients with neovascular AMD vs. control individuals had migraine before the index date (6.1% vs. 4.9%; P < .001), with an adjusted (for age, sex, monthly income, geographic location, urbanization, hyperlipidemia, diabetes, coronary heart disease, hypertension, and cataract surgery) odds ratio of 1.201 (P < .001).

 

Study details: This nationwide, population-based study included 20,333 patients aged 40 years or older diagnosed with neovascular AMD in at least 2 claims, with the first diagnosis date defined as the index date. They were propensity score-matched (1:4) with 81,332 nonneovascular AMD control individuals.

 

Disclosures: No source of funding was declared. None of the authors identified any conflicts of interest.

 

Source: Kuang TM et al. Sci Rep. 2022;12:1792 (Feb 2). Doi: 10.1038/s41598-022-05638-5

Key clinical point: Patients with migraine present with a 20% higher risk of developing neovascular age-related macular degeneration (AMD) compared with individuals without migraine.

 

Main finding: A significantly higher proportion of patients with neovascular AMD vs. control individuals had migraine before the index date (6.1% vs. 4.9%; P < .001), with an adjusted (for age, sex, monthly income, geographic location, urbanization, hyperlipidemia, diabetes, coronary heart disease, hypertension, and cataract surgery) odds ratio of 1.201 (P < .001).

 

Study details: This nationwide, population-based study included 20,333 patients aged 40 years or older diagnosed with neovascular AMD in at least 2 claims, with the first diagnosis date defined as the index date. They were propensity score-matched (1:4) with 81,332 nonneovascular AMD control individuals.

 

Disclosures: No source of funding was declared. None of the authors identified any conflicts of interest.

 

Source: Kuang TM et al. Sci Rep. 2022;12:1792 (Feb 2). Doi: 10.1038/s41598-022-05638-5

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Dietary nutrient patterns may influence the intensity and duration of migraine headaches

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Key clinical point: Clinical management of pain intensity and disability in patients with migraine would benefit from closely monitoring their dietary nutrient patterns.

 

Main finding: After adjusting for all confounders, higher consumption of vitamins B1 (thiamine), B3 (niacin), and B9 (folic acid). and carbohydrate, protein, and total fiber was positively associated with pain intensity as assessed using the Visual Analogue Scale (regression coefficient [β] 0.37; P < .001), whereas that of vitamins A, K, C, B6, B2 (riboflavin), and calcium and magnesium was negatively associated with migraine-related disability measured by Migraine Disability Assessment (β −3.14; P = .01).

 

Study details: Findings are from a cross-sectional study involving 266 adult women with migraine and no chronic disease.

 

Disclosures: The study was sponsored by the Tehran University of Medical Sciences, Iran. The authors reported having no conflicts of interest.

 

Source: Bahrampour N et al. Br J Nutr. 2022 (Jan 17). Doi: 10.1017/S0007114522000046

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Key clinical point: Clinical management of pain intensity and disability in patients with migraine would benefit from closely monitoring their dietary nutrient patterns.

 

Main finding: After adjusting for all confounders, higher consumption of vitamins B1 (thiamine), B3 (niacin), and B9 (folic acid). and carbohydrate, protein, and total fiber was positively associated with pain intensity as assessed using the Visual Analogue Scale (regression coefficient [β] 0.37; P < .001), whereas that of vitamins A, K, C, B6, B2 (riboflavin), and calcium and magnesium was negatively associated with migraine-related disability measured by Migraine Disability Assessment (β −3.14; P = .01).

 

Study details: Findings are from a cross-sectional study involving 266 adult women with migraine and no chronic disease.

 

Disclosures: The study was sponsored by the Tehran University of Medical Sciences, Iran. The authors reported having no conflicts of interest.

 

Source: Bahrampour N et al. Br J Nutr. 2022 (Jan 17). Doi: 10.1017/S0007114522000046

Key clinical point: Clinical management of pain intensity and disability in patients with migraine would benefit from closely monitoring their dietary nutrient patterns.

 

Main finding: After adjusting for all confounders, higher consumption of vitamins B1 (thiamine), B3 (niacin), and B9 (folic acid). and carbohydrate, protein, and total fiber was positively associated with pain intensity as assessed using the Visual Analogue Scale (regression coefficient [β] 0.37; P < .001), whereas that of vitamins A, K, C, B6, B2 (riboflavin), and calcium and magnesium was negatively associated with migraine-related disability measured by Migraine Disability Assessment (β −3.14; P = .01).

 

Study details: Findings are from a cross-sectional study involving 266 adult women with migraine and no chronic disease.

 

Disclosures: The study was sponsored by the Tehran University of Medical Sciences, Iran. The authors reported having no conflicts of interest.

 

Source: Bahrampour N et al. Br J Nutr. 2022 (Jan 17). Doi: 10.1017/S0007114522000046

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Migraine negatively correlates with large artery atherosclerosis in ischemic stroke

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Key clinical point: Migraine, migraine with aura (MWA), and migraine without aura (MWoA) are negatively associated with large artery atherosclerosis (LAA) in young patients with ischemic stroke, irrespective of traditional vascular risk factors.

Major finding: LAA of any grade was significantly less frequent in patients with migraine (P < .001), MWA (P < .001), and MWoA (P = .005) vs. those without migraine. Migraine (adjusted odds ratio [aOR] 0.44; P = .005), MWoA (aOR 0.42; P = .020), and MWA (aOR 0.47; P = .037) vs. no migraine showed a negative association with LAA of any grade.

Study details: Findings are from a cross-sectional study including 415 patients aged 18-54 years with first-ever acute ischemic stroke, of which 144 had migraine (MWA, n = 76; MWoA, n = 68).

Disclosures: No funding was received for this study. The authors declared no conflicts of interest.

 

Source: Gollion C et al. Headache. 2022;62(2):191-7 (Feb 5). Doi: 10.1111/head.14265

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Key clinical point: Migraine, migraine with aura (MWA), and migraine without aura (MWoA) are negatively associated with large artery atherosclerosis (LAA) in young patients with ischemic stroke, irrespective of traditional vascular risk factors.

Major finding: LAA of any grade was significantly less frequent in patients with migraine (P < .001), MWA (P < .001), and MWoA (P = .005) vs. those without migraine. Migraine (adjusted odds ratio [aOR] 0.44; P = .005), MWoA (aOR 0.42; P = .020), and MWA (aOR 0.47; P = .037) vs. no migraine showed a negative association with LAA of any grade.

Study details: Findings are from a cross-sectional study including 415 patients aged 18-54 years with first-ever acute ischemic stroke, of which 144 had migraine (MWA, n = 76; MWoA, n = 68).

Disclosures: No funding was received for this study. The authors declared no conflicts of interest.

 

Source: Gollion C et al. Headache. 2022;62(2):191-7 (Feb 5). Doi: 10.1111/head.14265

Key clinical point: Migraine, migraine with aura (MWA), and migraine without aura (MWoA) are negatively associated with large artery atherosclerosis (LAA) in young patients with ischemic stroke, irrespective of traditional vascular risk factors.

Major finding: LAA of any grade was significantly less frequent in patients with migraine (P < .001), MWA (P < .001), and MWoA (P = .005) vs. those without migraine. Migraine (adjusted odds ratio [aOR] 0.44; P = .005), MWoA (aOR 0.42; P = .020), and MWA (aOR 0.47; P = .037) vs. no migraine showed a negative association with LAA of any grade.

Study details: Findings are from a cross-sectional study including 415 patients aged 18-54 years with first-ever acute ischemic stroke, of which 144 had migraine (MWA, n = 76; MWoA, n = 68).

Disclosures: No funding was received for this study. The authors declared no conflicts of interest.

 

Source: Gollion C et al. Headache. 2022;62(2):191-7 (Feb 5). Doi: 10.1111/head.14265

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Caffeine cessation beneficial in episodic migraine

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Key clinical point: Chronic caffeine use is associated with a reduced cerebrovascular reactivity (CVR) in the posterior circulation of patients with episodic migraine, whereas caffeine cessation is associated with a significantly improved CVR.

Major finding: The breath-holding index (BHI) of the posterior cerebral arteries (PCA) was lower in caffeine users vs. nonusers (median 1.1 vs. 1.3; P = .03), with caffeine cessation being associated with a significant improvement in PCA-BHI (median 1.1 at baseline vs. 1.3 at 3 months of follow-up; P = .03) and independently associated with changes in PCA-BHI (adjusted unstandardized β 0.27; P = .04).

Study details: Findings are from a prospective, longitudinal, observational study of 84 adult patients with episodic migraine and no vascular risk factors, of whom 56 were caffeine users and were instructed to discontinue caffeine use.

Disclosures: The study was supported by the Dong-A ST and National Research Foundation of Korea grant funded by the Korean government. The authors declared no conflicts of interest.

 

Source: Gil Y-E et al. Headache. 2022;62(2):169-75 (Feb 3). Doi: 10.1111/head.14263

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Key clinical point: Chronic caffeine use is associated with a reduced cerebrovascular reactivity (CVR) in the posterior circulation of patients with episodic migraine, whereas caffeine cessation is associated with a significantly improved CVR.

Major finding: The breath-holding index (BHI) of the posterior cerebral arteries (PCA) was lower in caffeine users vs. nonusers (median 1.1 vs. 1.3; P = .03), with caffeine cessation being associated with a significant improvement in PCA-BHI (median 1.1 at baseline vs. 1.3 at 3 months of follow-up; P = .03) and independently associated with changes in PCA-BHI (adjusted unstandardized β 0.27; P = .04).

Study details: Findings are from a prospective, longitudinal, observational study of 84 adult patients with episodic migraine and no vascular risk factors, of whom 56 were caffeine users and were instructed to discontinue caffeine use.

Disclosures: The study was supported by the Dong-A ST and National Research Foundation of Korea grant funded by the Korean government. The authors declared no conflicts of interest.

 

Source: Gil Y-E et al. Headache. 2022;62(2):169-75 (Feb 3). Doi: 10.1111/head.14263

Key clinical point: Chronic caffeine use is associated with a reduced cerebrovascular reactivity (CVR) in the posterior circulation of patients with episodic migraine, whereas caffeine cessation is associated with a significantly improved CVR.

Major finding: The breath-holding index (BHI) of the posterior cerebral arteries (PCA) was lower in caffeine users vs. nonusers (median 1.1 vs. 1.3; P = .03), with caffeine cessation being associated with a significant improvement in PCA-BHI (median 1.1 at baseline vs. 1.3 at 3 months of follow-up; P = .03) and independently associated with changes in PCA-BHI (adjusted unstandardized β 0.27; P = .04).

Study details: Findings are from a prospective, longitudinal, observational study of 84 adult patients with episodic migraine and no vascular risk factors, of whom 56 were caffeine users and were instructed to discontinue caffeine use.

Disclosures: The study was supported by the Dong-A ST and National Research Foundation of Korea grant funded by the Korean government. The authors declared no conflicts of interest.

 

Source: Gil Y-E et al. Headache. 2022;62(2):169-75 (Feb 3). Doi: 10.1111/head.14263

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Atorvastatin plus nortriptyline: A promising combination for migraine therapy

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Key clinical point: Compared with nortriptyline alone, its combination with atorvastatin significantly reduces the frequency of headache and improves the quality of life (QOL) in patients with migraine; however, the effect on migraine intensity is nonsignificant.

Major finding: Atorvastatin plus nortriptyline vs. nortriptyline alone led to a significantly lower headache frequency (P = .004) at week 24 in addition to a significant improvement in the QOL at weeks 14 and 24 (both P = .001); however, no significant difference was observed in the headache intensity over 24 weeks.

Study details: This prospective, triple-blind, randomized controlled trial included 68 adult patients with migraine who were randomly assigned to receive atorvastatin plus nortriptyline (n = 34) or placebo plus nortriptyline (n = 34) for 24 weeks.

Disclosures: The study was supported by a grant from the Research and Technology Department of Shahid Sadoughi University of Medical Sciences, Yazd, Iran. The authors reported having no conflicts of interest.

 

Source: Sherafat M et al. Neurol Res. 2022 (Jan 17). Doi: 10.1080/01616412.2021

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Key clinical point: Compared with nortriptyline alone, its combination with atorvastatin significantly reduces the frequency of headache and improves the quality of life (QOL) in patients with migraine; however, the effect on migraine intensity is nonsignificant.

Major finding: Atorvastatin plus nortriptyline vs. nortriptyline alone led to a significantly lower headache frequency (P = .004) at week 24 in addition to a significant improvement in the QOL at weeks 14 and 24 (both P = .001); however, no significant difference was observed in the headache intensity over 24 weeks.

Study details: This prospective, triple-blind, randomized controlled trial included 68 adult patients with migraine who were randomly assigned to receive atorvastatin plus nortriptyline (n = 34) or placebo plus nortriptyline (n = 34) for 24 weeks.

Disclosures: The study was supported by a grant from the Research and Technology Department of Shahid Sadoughi University of Medical Sciences, Yazd, Iran. The authors reported having no conflicts of interest.

 

Source: Sherafat M et al. Neurol Res. 2022 (Jan 17). Doi: 10.1080/01616412.2021

Key clinical point: Compared with nortriptyline alone, its combination with atorvastatin significantly reduces the frequency of headache and improves the quality of life (QOL) in patients with migraine; however, the effect on migraine intensity is nonsignificant.

Major finding: Atorvastatin plus nortriptyline vs. nortriptyline alone led to a significantly lower headache frequency (P = .004) at week 24 in addition to a significant improvement in the QOL at weeks 14 and 24 (both P = .001); however, no significant difference was observed in the headache intensity over 24 weeks.

Study details: This prospective, triple-blind, randomized controlled trial included 68 adult patients with migraine who were randomly assigned to receive atorvastatin plus nortriptyline (n = 34) or placebo plus nortriptyline (n = 34) for 24 weeks.

Disclosures: The study was supported by a grant from the Research and Technology Department of Shahid Sadoughi University of Medical Sciences, Yazd, Iran. The authors reported having no conflicts of interest.

 

Source: Sherafat M et al. Neurol Res. 2022 (Jan 17). Doi: 10.1080/01616412.2021

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Rimegepant lowers MMDs and tablet use and improves HRQoL in migraine

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Key clinical point: Rimegepant on a patient treated as needed (PRN) basis reduces monthly migraine days (MMD) without increasing the monthly tablet use and improves health-related quality of life (HRQoL) in patients with acute migraine.

Major finding: Rimegepant reduced the mean MMD from 10.9 days at baseline to 8.9 days by week 52 and led to an increase of 0.08 quality-adjusted life years. The mean monthly tablet use decreased from 7.9 tablets to 7.3 tablets between weeks 4-8 and 48-52.

Study details: This was a post hoc analysis of the phase 2/3 safety BHV3000-201 study including 1,044 patients with a ≥1-year history of migraine and ≥6 MMD who received 75 mg rimegepant up to once daily PRN for up to 52 weeks.

Disclosures: The study was sponsored by Biohaven Pharmaceuticals. CP Schreiber reported being a speaker for various organizations, including Biohaven. The rest of the authors are employees and stock/stock option owners of Biohaven or Broadstreet HEOR (funded by the former).

 

Source: Johnston K et al. J Headache Pain. 2022;23:10 (Jan 17). Doi: 10.1186/s10194-021-01378-5

 

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Key clinical point: Rimegepant on a patient treated as needed (PRN) basis reduces monthly migraine days (MMD) without increasing the monthly tablet use and improves health-related quality of life (HRQoL) in patients with acute migraine.

Major finding: Rimegepant reduced the mean MMD from 10.9 days at baseline to 8.9 days by week 52 and led to an increase of 0.08 quality-adjusted life years. The mean monthly tablet use decreased from 7.9 tablets to 7.3 tablets between weeks 4-8 and 48-52.

Study details: This was a post hoc analysis of the phase 2/3 safety BHV3000-201 study including 1,044 patients with a ≥1-year history of migraine and ≥6 MMD who received 75 mg rimegepant up to once daily PRN for up to 52 weeks.

Disclosures: The study was sponsored by Biohaven Pharmaceuticals. CP Schreiber reported being a speaker for various organizations, including Biohaven. The rest of the authors are employees and stock/stock option owners of Biohaven or Broadstreet HEOR (funded by the former).

 

Source: Johnston K et al. J Headache Pain. 2022;23:10 (Jan 17). Doi: 10.1186/s10194-021-01378-5

 

Key clinical point: Rimegepant on a patient treated as needed (PRN) basis reduces monthly migraine days (MMD) without increasing the monthly tablet use and improves health-related quality of life (HRQoL) in patients with acute migraine.

Major finding: Rimegepant reduced the mean MMD from 10.9 days at baseline to 8.9 days by week 52 and led to an increase of 0.08 quality-adjusted life years. The mean monthly tablet use decreased from 7.9 tablets to 7.3 tablets between weeks 4-8 and 48-52.

Study details: This was a post hoc analysis of the phase 2/3 safety BHV3000-201 study including 1,044 patients with a ≥1-year history of migraine and ≥6 MMD who received 75 mg rimegepant up to once daily PRN for up to 52 weeks.

Disclosures: The study was sponsored by Biohaven Pharmaceuticals. CP Schreiber reported being a speaker for various organizations, including Biohaven. The rest of the authors are employees and stock/stock option owners of Biohaven or Broadstreet HEOR (funded by the former).

 

Source: Johnston K et al. J Headache Pain. 2022;23:10 (Jan 17). Doi: 10.1186/s10194-021-01378-5

 

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Galcanezumab improves functioning and reduces disability in treatment-resistant migraine

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Key clinical point: Galcanezumab improves functioning and decreases disability in patients with treatment-resistant migraine.

 

Main finding: At month 3, galcanezumab vs. placebo caused a greater improvement in the Migraine-Specific Quality of Life Questionnaire (version 2.1 Role Function-Restrictive) (least-squares mean [LSM] change 23.19 vs. 10.66; P ≤ .0001] and European Quality of Life-5 Dimensions-5 Level Visual Analog Scale (LSM change 3.38 vs. −0.086; P = .0277) scores and a greater reduction in Migraine Disability Assessment total scores (LSM chang, −21.10 vs. −3.30; P ≤ .0001).

 

Study details: Findings are from the phase 3b CONQUER trial including 462 adult patients with episodic or chronic migraine and no response to previous 2-4 migraine preventive treatment categories who were randomly assigned to double-blind treatment with galcanezumab (n = 232) or placebo (n = 230) for 3 months followed by 3-month open-label treatment with galcanezumab.

 

Disclosures: Eli Lilly and Company sponsored the study. SJ Tepper and J Ailani declared receiving research grants, speaker's/advisory board member's honoraria, or institutional research funding for clinical trials from various sources, including Eli Lilly. The rest of the authors are employees and stockholders of Eli Lilly.

 

Source: Tepper SJ et al. Clin Drug Investig. 2022 (Jan 18). Doi: 10.1007/s40261-021-01115-5

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Key clinical point: Galcanezumab improves functioning and decreases disability in patients with treatment-resistant migraine.

 

Main finding: At month 3, galcanezumab vs. placebo caused a greater improvement in the Migraine-Specific Quality of Life Questionnaire (version 2.1 Role Function-Restrictive) (least-squares mean [LSM] change 23.19 vs. 10.66; P ≤ .0001] and European Quality of Life-5 Dimensions-5 Level Visual Analog Scale (LSM change 3.38 vs. −0.086; P = .0277) scores and a greater reduction in Migraine Disability Assessment total scores (LSM chang, −21.10 vs. −3.30; P ≤ .0001).

 

Study details: Findings are from the phase 3b CONQUER trial including 462 adult patients with episodic or chronic migraine and no response to previous 2-4 migraine preventive treatment categories who were randomly assigned to double-blind treatment with galcanezumab (n = 232) or placebo (n = 230) for 3 months followed by 3-month open-label treatment with galcanezumab.

 

Disclosures: Eli Lilly and Company sponsored the study. SJ Tepper and J Ailani declared receiving research grants, speaker's/advisory board member's honoraria, or institutional research funding for clinical trials from various sources, including Eli Lilly. The rest of the authors are employees and stockholders of Eli Lilly.

 

Source: Tepper SJ et al. Clin Drug Investig. 2022 (Jan 18). Doi: 10.1007/s40261-021-01115-5

Key clinical point: Galcanezumab improves functioning and decreases disability in patients with treatment-resistant migraine.

 

Main finding: At month 3, galcanezumab vs. placebo caused a greater improvement in the Migraine-Specific Quality of Life Questionnaire (version 2.1 Role Function-Restrictive) (least-squares mean [LSM] change 23.19 vs. 10.66; P ≤ .0001] and European Quality of Life-5 Dimensions-5 Level Visual Analog Scale (LSM change 3.38 vs. −0.086; P = .0277) scores and a greater reduction in Migraine Disability Assessment total scores (LSM chang, −21.10 vs. −3.30; P ≤ .0001).

 

Study details: Findings are from the phase 3b CONQUER trial including 462 adult patients with episodic or chronic migraine and no response to previous 2-4 migraine preventive treatment categories who were randomly assigned to double-blind treatment with galcanezumab (n = 232) or placebo (n = 230) for 3 months followed by 3-month open-label treatment with galcanezumab.

 

Disclosures: Eli Lilly and Company sponsored the study. SJ Tepper and J Ailani declared receiving research grants, speaker's/advisory board member's honoraria, or institutional research funding for clinical trials from various sources, including Eli Lilly. The rest of the authors are employees and stockholders of Eli Lilly.

 

Source: Tepper SJ et al. Clin Drug Investig. 2022 (Jan 18). Doi: 10.1007/s40261-021-01115-5

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Rheumatoid arthritis: Baricitinib more effective than TNF inhibitors in real world

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Key clinical point: In patients with rheumatoid arthritis (RA), baricitinib showed better treatment responses than tumor necrosis factor (TNF) inhibitors, whereas treatment response for tofacitinib was not significantly different vs. baricitinib or biological disease-modifying antirheumatic drugs (bDMARD).

Major finding: At 1 year, TNFi vs. baricitinib showed lower European Alliance of Associations for Rheumatology (difference 4.3%; 95% CI −8.7% to 0.1%), Health Assessment Questionnaire-Disability Index improvement (difference −9.9%; 95% CI −14.4% to −5.4%), and Clinical Disease Activity Index remission (difference −6%; 95% CI −9.8% to −2.2%). Tofacitinib showed similar treatment responses vs. bDMARDs or baricitinib.

Study details: This was a nationwide cohort study involving patients with RA who initiated baricitinib (n = 1,420), tofacitinib (n = 316), abatacept (n = 1,050), interleukin-6 inhibitors (n = 849), rituximab (n = 1,101), or TNF inhibitors (n = 6,036).

Disclosures: This work was supported by the Swedish Research Council and others. J Askling, K Chatzidionysiou, and C Turesson reported receiving research grants and consulting and speaker fees from various sources. A Kastbom reported being employed by Sanofi.

Source: Barbulescu A et al. Rheumatology (Oxford). 2022 (Feb 3). Doi: 10.1093/rheumatology/keac068

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Key clinical point: In patients with rheumatoid arthritis (RA), baricitinib showed better treatment responses than tumor necrosis factor (TNF) inhibitors, whereas treatment response for tofacitinib was not significantly different vs. baricitinib or biological disease-modifying antirheumatic drugs (bDMARD).

Major finding: At 1 year, TNFi vs. baricitinib showed lower European Alliance of Associations for Rheumatology (difference 4.3%; 95% CI −8.7% to 0.1%), Health Assessment Questionnaire-Disability Index improvement (difference −9.9%; 95% CI −14.4% to −5.4%), and Clinical Disease Activity Index remission (difference −6%; 95% CI −9.8% to −2.2%). Tofacitinib showed similar treatment responses vs. bDMARDs or baricitinib.

Study details: This was a nationwide cohort study involving patients with RA who initiated baricitinib (n = 1,420), tofacitinib (n = 316), abatacept (n = 1,050), interleukin-6 inhibitors (n = 849), rituximab (n = 1,101), or TNF inhibitors (n = 6,036).

Disclosures: This work was supported by the Swedish Research Council and others. J Askling, K Chatzidionysiou, and C Turesson reported receiving research grants and consulting and speaker fees from various sources. A Kastbom reported being employed by Sanofi.

Source: Barbulescu A et al. Rheumatology (Oxford). 2022 (Feb 3). Doi: 10.1093/rheumatology/keac068

Key clinical point: In patients with rheumatoid arthritis (RA), baricitinib showed better treatment responses than tumor necrosis factor (TNF) inhibitors, whereas treatment response for tofacitinib was not significantly different vs. baricitinib or biological disease-modifying antirheumatic drugs (bDMARD).

Major finding: At 1 year, TNFi vs. baricitinib showed lower European Alliance of Associations for Rheumatology (difference 4.3%; 95% CI −8.7% to 0.1%), Health Assessment Questionnaire-Disability Index improvement (difference −9.9%; 95% CI −14.4% to −5.4%), and Clinical Disease Activity Index remission (difference −6%; 95% CI −9.8% to −2.2%). Tofacitinib showed similar treatment responses vs. bDMARDs or baricitinib.

Study details: This was a nationwide cohort study involving patients with RA who initiated baricitinib (n = 1,420), tofacitinib (n = 316), abatacept (n = 1,050), interleukin-6 inhibitors (n = 849), rituximab (n = 1,101), or TNF inhibitors (n = 6,036).

Disclosures: This work was supported by the Swedish Research Council and others. J Askling, K Chatzidionysiou, and C Turesson reported receiving research grants and consulting and speaker fees from various sources. A Kastbom reported being employed by Sanofi.

Source: Barbulescu A et al. Rheumatology (Oxford). 2022 (Feb 3). Doi: 10.1093/rheumatology/keac068

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Clinical Edge Journal Scan
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